A Randomized Controlled Trial on the Effects of Rate and/or Presence of Dextrose on the Labor Course of Nulliparas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Length of labor
研究概览
简要总结
This randomized controlled trial aims to compare three groups of intravenous fluids and their impact on labor: 1) 125 mL/hr of 5% dextrose in normal saline 2) 250 mL/hr of normal saline 3) 250 mL/hr of 5% dextrose in normal saline
详细描述
Currently, patients who arrive to labor and delivery automatically receive IV fluid hydration as part of a standard order set. The current default IV fluid order is 125mL/hr of 5% dextrose, either in normal saline or lactated ringers.
Any patient delivering for the first time presenting to labor and delivery in active labor will be screened. If they meet inclusion requirements they will be offered enrollment.
Subjects will be blindly randomized to receive one of three different types of IV fluids:
- 5% dextrose Normal saline (Normal saline plus 5g/dl of glucose) at 125 mL/hr (the current LBMMC default inpatient IV order set)
- Normal saline (a solution containing sodium and chloride) at 250 mL/hr
- 2.5% dextrose Normal saline at 125 mL/hr
- Management of labor will be at the discretion of the attending physician(s).
- Maternal outcomes to be measured include: 1) total amount of IV fluids administered, 2) length of labor, 3) epidural use, 4) oxytocin use, 5) mode of delivery, 6) development of maternal infections or other morbidity such as postpartum hemorrhage.
- Neonatal outcomes to be measured include: 1) birth weight, 2) Apgar scores, 3) hospital course (nursery placement and length of stay), 4) need for treatment of jaundice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Primiparous
- •Singleton gestation
- •Vertex presentation
- •Spontaneous active labor with or without pitocin augmentation
- •Gestational age > 36 weeks
- •Cervical dilation 3 to 5 cm with or without ruptured membranes
排除标准
- •• Multiparous
- •Pregestational or gestational diabetes mellitus
- •Preeclampsia at admission
- •Previous cesarean section
- •Non-vertex presentation
- •Multiple gestation
- •Chorioamnionitis at admission
- •Intrauterine growth restriction (< 10th percentile)
- •Patients admitted for induction
- •BMI > 50
研究组 & 干预措施
D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
干预措施: Dextrose (Other)
D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
干预措施: Dextrose (Other)
D5NS at 125 mL/hr
5% dextrose in normal saline at 125 mL/hr
干预措施: Normal Saline (Other)
D2.5NS at 250mL/hr
2.5% dextrose in normal saline at 250 mL/hr
干预措施: Normal Saline (Other)
NS at 250mL/hr
Normal saline at 250mL/hr
干预措施: Normal Saline (Other)
结局指标
主要结局
Length of labor
时间窗: Time from fluid initiation to delivery
次要结局
- Time of second stage of labor(Time from initiation of pushing to delivery)
